BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

PHASE4RecruitingINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2027

Conditions
Hepatic EncephalopathyDecompensated CirrhosisMinimal Hepatic Encephalopathy
Interventions
DRUG

Oral Branched chain Amino acid

The active drug BCAA supplement will be dispensed in a dose of 15 gm once daily x 12 weeks

DRUG

Rifaximin 550 MG

Active drug rifaximin will be dispensed in a dose of 550mg twice daily x 12 weeks

DRUG

Lactulose

Both groups will be treated with will be treated with 30-60 ml lactulose three times a day to ensure passage of 2-3 semisoft stools per day

DRUG

Placebo for BCAA

A placebo comparator of 15 gm of skimmed milk powder will be used.

DRUG

Placebo for Rifaximin 550mg

Identical placebo sugar pills will be used as a placebo.

Trial Locations (1)

Unknown

RECRUITING

PGIMER, Chandigarh

All Listed Sponsors
collaborator

Indian Council of Medical Research

OTHER_GOV

lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT06538077 - BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE | Biotech Hunter | Biotech Hunter